Impella 5.5 as a bridge to heart transplantation: Waitlist outcomes in the United States.

OBJECTIVES: The 2018 United Network for Organ Sharing allocation policy change has led to a significant increase in the use of mechanical circulatory support devices in patients listed for orthotopic heart transplantation. However, there has been a paucity of data regarding the newest generation Impella 5.5, which received FDA approval in 2019. METHODS: The United Network for Organ Sharing registry was queried for all adults awaiting orthotopic heart transplantation who received Impella 5.5 support during their listing period. Waitlist, device, and early post-transplant outcomes were assessed. RESULTS: A total of 464 patients received Impella 5.5 support during their listing period with a median waitlist time of 19 days. Among them, 402 (87%) patients were ultimately transplanted, with 378 (81%) being directly bridged to transplant with the device. Waitlist death (7%) and clinical deterioration (5%) were the most common reasons for waitlist removal. Device complications and failure were uncommon (<5%). The most common post-transplant complication was acute kidney injury requiring dialysis (16%). Survival at 1-year post-transplant survival was 89.5%. CONCLUSION: Since its approval, the Impella 5.5 has been increasingly used as a bridge to transplant. This analysis demonstrates robust waitlist and post-transplant outcomes with minimal device-related and postoperative complications.

Subacute groin complications related to ECMO cannulation are associated with longer hospitalizations.

Subacute groin complications associated with extracorporeal membrane oxygenation (ECMO) cannulation are well recognized, yet their effects on clinical outcomes remain unknown. This single-center, retrospective study reviewed all patients receiving venoarterial ECMO from 01/2017 to 02/2020. Cohorts analyzed included transplanted patients (TPs) and non-transplanted patients (N-TPs) who did or did not develop ECMO-related subacute groin complications. Standard descriptive statistics were used for comparisons. Logistic regressions identified associated risk factors. Overall, 82/367 (22.3%) ECMO patients developed subacute groin complications, including 25/82 (30.5%) seromas/lymphoceles, 32/82 (39.0%) hematomas, 18/82 (22.0%) infections, and 7/82 (8.5%) non-specified collections. Of these, 20/82 (24.4%) underwent surgical interventions, most of which were muscle flaps (14/20, 70.0%). TPs had a higher incidence of subacute groin complications than N-TPs (14/28, 50.0% vs. 68/339, 20.1%, P = 0.001). Seromas/lymphoceles more often developed in TPs than N-TPs (10/14, 71.4% vs. 15/68, 22.1%, P = 0.001). Most patients with subacute groin complications survived to discharge (60/68, 88.2%). N-TPs who developed subacute groin complications had longer post-ECMO lengths of stay than those who did not (34 days, IQR 16-53 days vs. 17 days, IQR 8-34 days, P < 0.001). Post-ECMO length of stay was also longer among patients who underwent related surgical interventions compared to those who did not (50 days, IQR 35-67 days vs. 29 days, IQR 16-49 days, P = 0.007). Transplantation was the strongest risk factor for developing subacute groin complications (OR 3.91, CI95% 1.52-10.04, P = 0.005). Subacute groin complications and related surgical interventions are common after ECMO cannulation and are associated with longer hospital stays. When surgical management is warranted, muscle flaps may reduce lengths of stay compared to other surgical interventions.

HCV-Positive Allograft Use in Heart Transplantation Is Associated With Increased Access to Overdose Donors and Reduced Waitlist Mortality Without Compromising Outcomes.

BACKGROUND: Because of ongoing shortages of donors for heart transplantation, the use of donor candidates whose availabilities are the result of drug overdoses (ODs) has become increasingly prevalent, even though these donors carry a high preponderance of the now curable hepatitis C virus (HCV). This study investigated temporal trends and regional variabilities in HVC-positive (HCV+) allograft use in heart transplantation and assessed the relationship between the use of HCV+ graft donors and the use of OD donors as well as assessing waitlist and post-transplant outcomes. METHODS AND RESULTS: A retrospective review of the United Network for Organ Sharing database assessed adults listed for heart transplantation. Patients were stratified both temporally into pre-HCV and HCV eras related to HCV+ graft use trends and regionally by degree of HCV+ allograft use. Regions of high HCV+ donor use were associated with an increase in OD donor access by 7.8% across eras compared to 0.4% in low HCV+ donor-use regions. One-year waitlist mortality decreased from 4.7% to 2.5% across eras in high HCV+ donor-use regions (P= 0.001) and remained roughly the same as before in low HCV+ donor-use regions (3.0% vs 2.4%; P= 0.244.). Post-transplant survival at 1 year remained similar across eras. CONCLUSIONS: HCV+ donor allograft use can help to optimize donor use, decreasing waitlist mortality without compromising early survival. Ongoing assessment is essential to ensure long-term safety and efficacy of using HCV+ donors.

How Should ECMO Be Used Under Conditions of Severe Scarcity? A Population Study of Public Perception.

OBJECTIVE: To assess societal preferences regarding allocation of extracorporeal membrane oxygenation (ECMO) as a rescue option for select patients with coronavirus disease 2019 (COVID-19). DESIGN: Cross-sectional survey of a nationally representative sample. SETTING: Amazon Mechanical Turk platform. PARTICIPANTS: In total, responses from 1,041 members of Amazon Mechanical Turk crowd-sourcing platform were included. Participants were 37.9 ± 12.6 years old, generally white (65%), and college-educated (66.1%). Many reported working in a healthcare setting (22.5%) and having a friend or family member who was admitted to the hospital (43.8%) or died from COVID-19 (29.9%). MEASUREMENTS AND MAIN RESULTS: Although most reported an unwillingness to stay on ECMO for >one week without signs of recovery, participants were highly supportive of ECMO utilization as a life-preserving technique on a policy level. The majority (96.7%) advocated for continued use of ECMO to treat COVID patients during periods of resource scarcity but would prioritize those with highest likelihood of recovery (50%) followed by those who were sickest regardless of survival chances (31.7%). Patients >40 years old were more likely to prefer distributing ECMO on a first-come first-served basis (21.5% v 13.3%, p < 0.05). CONCLUSION: Even though participants expressed hesitation regarding ECMO in personal circumstances, they were uniformly in support of using ECMO to treat COVID patients at a policy level for others who might need it, even in the setting of severe scarcity.

Lack of volume-outcome association in ECMO bridge to heart transplantation.

BACKGROUND: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used as a bridge to cardiac transplantation. As the 2018 United Network for Organ Sharing (UNOS) heart allocation policy change elevated waitlist status for patients receiving mechanical circulatory support (MCS), we aimed to determine if a center's annual heart transplant volume was associated with ECMO-support duration and posttransplant outcomes. METHODS: Adults heart transplant candidates between January 1, 2011, and December 31, 2021, were isolated in the UNOS database. VA-ECMO use was identified at the time of listing for transplant. Average annual transplant volume was calculated by the center, with stratification as high (≥20 cardiac transplants, high volume center [HVC]) or low (<20 cardiac transplants, low volume center [LVC]) volume centers. Results are reported as mean (interquartile range) or n (%). RESULTS: In total, 543 patients at HVCs and 275 at LVCs were listed for transplant supported with VA-ECMO. Those listed at HVCs were more likely to be supported by intra-aortic balloon pump (103 [19%] vs. 32 [11.6%], p = .008) and inotropes (267 [49.2%] vs. 106 [38.5%], p = .004) at time of listing. Patients at HVCs received ECMO support for 6 [4-9] days, compared to 8 [4-15] days at low-volume centers (p = .030), and but were cannulated a similar time before listing (2 [1-5] vs. 3 [1-7] days, p = .517). There were no differences in rates of transplant (p = .2126), waitlist mortality (p = .8645), delisting due to clinical deterioration (p = .8419), or recovery (p = .1773) between groups. Among transplanted patients, there were no differences in support duration (6 [4-8] vs. 6 [4-10], p = .187), or time from registration to transplant (5 [2-20] vs. 7 [3-22] days, p = .560). Posttransplant survival did not vary (p = .293). CONCLUSIONS: LVCs can successfully bridge patients to transplant with VA-ECMO and achieve comparable outcomes to HVCs.

Impact of Socioeconomic Status on Outcomes After Ventricular Assist Device Implantation Using the Area Deprivation Index.

BACKGROUND: This study evaluates the Area Deprivation Index (ADI) as a novel prognostic metric of socioeconomic status for patients with a left ventricular assist device. METHODS AND RESULTS: A retrospective analysis of patients with a left ventricular assist device at a high-volume institution from 2007 to 2018 was conducted. Socioeconomic status was determined using the ADI, a multifactorial neighborhood-based metric where higher ADI denotes worse socioeconomic status. Patients were stratified into 4 ADI cohorts. Long-term survival was compared with multivariate analysis. Of the 380 patients stratified by ADI, 35 were in the 10th percentile or lower, 218 were in the 11th-50th percentile, 104 were in the 51st-89th percentile, and 23 were in the 90th percentile or higher. Baseline characteristics were comparable. On multivariate analysis, being male (hazard ratio [HR], 0.14; P = .01), bridge-to-transplant (HR, 0.14; P = .03), and not requiring biventricular support (HR, 0.02; P < .01) were protective, whereas chronic kidney disease (HR, 9.07; P < .01) and an elevated total bilirubin (HR, 3.56; P = .02) were harmful. The ADI as a continuous variable did not affect survival; however, categorically, a higher ADI was protective (ADI 90-100: HR, 0.07; P = .04). CONCLUSIONS: Socioeconomically disadvantaged patients had noninferior outcomes given appropriate pre-implant optimization and workup.

Association of donor hypertension and outcomes in orthotopic heart transplantation.

The present study examined the impact of donor hypertension on recipient survival and offer acceptance practices in the United States. This was a retrospective study of all patients undergoing OHT from 1995 to 2019 using the United Network for Organ Sharing and Potential Transplant Recipient file databases. Hypertensive donors were stratified by Short (0-5 years) and Prolonged (> 5 years) hypertension. Multivariable logistic regression was used to analyze offer acceptance practices while Cox proportional-hazards models were used to compare mortality across groups. Of 38,338 heart transplants meeting study criteria, 5662 were procured from hypertensive donors (69% Short and 31% Prolonged). After adjustment, Prolonged donor hypertension was associated with increased mortality (hazard ratio, HR, 1.31, 95% confidence interval, CI, 1.04-1.64), while recipients of Short donors experienced no decrement in post-transplant survival. Both Short and Prolonged hypertension were independently associated with decreased odds of offer acceptance (odds ratio, OR .92 95%CI: .88-.96 and OR .93 95%CI: .88-.99, respectively). While prolonged untreated hypertension in OHT donors is associated with a slight decrement in recipient survival, donors with ≤5 years of hypertension yielded similar outcomes. Donor hypertension was associated with reduced organ offer acceptance, highlighting a potential source of organ underutilization.

Heart transplant waiting list implications of increased ventricular assist device use as a bridge strategy: A national analysis.

The use of ventricular assist devices (VADs) as a bridge to heart transplant (HT) is increasing, while HT volume remains stagnant. This may portend longer waiting times and an otherwise more competitive environment for all patients on the HT waiting list. A retrospective analysis of patients who were listed for HT in the United Network for Organ Sharing (UNOS) database from 2000 to 2015 was conducted. Mean waiting time, proportion of HT reception (%HT), proportion of death (%death), and proportion of waiting list removal (%removal) were calculated across three eras: Era 1 (2000-2007), Era 2 (2008-2011), and Era 3 (2012-2015). During the study period, 29 728 patients successfully underwent HT. 19 127 (64.3%) were directly transplanted (direct HT); 4491 (15.1%) received VADs prior to listing as a bridge to decision (BTD); and 4593 (15.5%) received VADs after listing as a bridge to transplant (BTT). Across the three eras, the average number of registrants per year grew. Among all groups, waiting time increased across the eras. %HT generally decreased in the BTD and BTT groups but remained constant in the direct HT group. %removal increased, while %death decreased in all group across the eras. Waiting time for HT increased from 2000 to 2015. Patients with VADs as a bridge strategy experienced decreasing %HT and increasing %removal but stable survival. Improvements in VAD safety and durability will ensure their success as part of a bridge strategy to HT under the new UNOS allocation policy.

The learning curve of robotic coronary arterial bypass surgery: A report from the STS database.

BACKGROUND: There is limited data to inform minimum case requirements for training in robotically assisted coronary artery bypass grafting (RA-CABG). Current recommendations rely on nonclinical endpoints and expert opinion. OBJECTIVES: To determine the minimum number of RA-CABG procedures required to achieve stable clinical outcomes. METHODS: We included isolated RA-CABG in the Society of Thoracic Surgeons (STS) registry performed between 2014 and 2019 by surgeons without prior RA-CABG experience. Outcomes were approach conversion, reoperation, major morbidity or mortality, and procedural success. Case sequence number was used as a continuous variable in logistic regression with restricted cubic splines with fixed effects. Outcomes were compared between operations performed earlier versus later in case sequences using unadjusted and adjusted metrics. RESULTS: There were 1195 cases performed by 114 surgeons. A visual inflection point occurs by a surgeon's 10th procedure for approach conversion, major morbidity or mortality, and overall procedural success after which outcomes stabilize. There was a significant decrease in the rate of approach conversion (7.7% and 2.5%), reoperation (18.9% and 10.8%), and major morbidity or mortality (21.7% and 12.9%), as well as an increase in the rate of procedural success (72.9% and 85.3%) with increasing experience between groups. In a multivariable logistic regression model, case sequences of >10 were an independent predictor of decreased approach conversion (odds ratio [OR]: 0.27; 95% confidence interval [CI]: 0.09-0.84) and increased rate procedural success (OR: 1.96; 95% CI: 1.00-3.84). CONCLUSIONS: The learning curve for RA-CABG is initially steep, but stable clinical outcomes are achieved after the 10th procedure.

COVID-19 and cardiothoracic surgery: Effects on training and workforce utilization in a global pandemic.

BACKGROUND: The COVID-19 pandemic has disrupted all aspects of healthcare, including cardiothoracic surgery (CTS). We sought to determine the pandemic's impact on CTS trainees' educational experiences. METHODS: A survey was developed and distributed to members of the Thoracic Surgery Residents Association and other international CTS trainees. Trainees were asked to evaluate their cumulative experiences and share their overall perceptions of how CTS training had been impacted during the earliest months of the COVID-19 pandemic (i.e., since March 01, 2020). Surveys were distributed and responses were recorded June 25-August 05, 2020. In total, 748 surveys were distributed and 166 responses were received (overall response rate 22.2%). Of these, 126 of 166 responses (75.9%) met inclusion criteria for final analysis. RESULTS: Final responses analyzed included 45 of 126 (35.7%) United States (US) and 81 of 126 (64.3%) international trainees, including 101 of 126 (80.2%) senior and 25 of 126 (19.8%) junior trainees. Most respondents (76/126, 43.2%) lost over 1 week in the hospital due to the pandemic. Juniors (12/25, 48.0%) were more likely than seniors (20/101, 19.8%) to be reassigned to COVID-19-specific units (p < .01). Half of trainees (63/126) reported their case volumes were reduced by over 50%. US trainees (42/45, 93.3%) were more likely than international trainees (58/81, 71.6%) to report reduced operative case volumes (p < .01). Most trainees (104/126, 83%) believed their overall clinical acumen was not adversely impacted by the pandemic. CONCLUSIONS: CTS trainees in the United States and abroad have been significantly impacted by the COVID-19 pandemic, with time lost in the hospital, decreased operative experiences, less time on CTS services, and frequent reassignment to COVID-19-specific care settings.

Relationship Between Change in Heart Transplant Volume and Outcomes: A National Analysis.

INTRODUCTION: Although volume-outcome relationships in transplantation have been well-defined, the effects of large changes in center volume are less well understood. The purpose of the current study was to examine the impact of changes in center volume on outcomes after heart transplantation. METHODS: Retrospective analysis was performed of adult patients undergoing heart transplant between 2000 and 2017 identified in the United Network for Organ Sharing database. Exclusions included annual volume <10. Patients were grouped according to percentage change in center volume from the previous year. Multivariable Cox regression models were adjusted for the significant preoperative variance identified on univariate analyses. RESULTS: Of the 29,851 transplants during the study period, 64% were at centers with stable volume (±25% annual change), whereas 10% were performed at contracting (-25% change or more) and 26% were performed at growing (+25% change or more) centers. Average volume was lower with contracting centers compared with stable or growing programs (21 vs 36, P< .001). Thirty-day mortality was greater in decreasing centers (6% vs 4%, P < .001), with more acute rejection treatments at 1y (27% vs 24% P < .001). The adjusted risk of mortality among contracting centers was 1.25 ([1.07-1.46], P= .004), whereas growing centers had unaffected risk (0.90 [0.79-1.02], P= .103). Causes of death were similar between groups. CONCLUSIONS: Rapid growth of transplant center volume has occurred at select centers in the United States without decrement in programmatic outcomes. Decreasing center volume has been associated with poorer outcomes, although the causative nature of this relationship requires further investigation.

Donor history of malignancy: A limited risk for heart transplant recipients.

Organ donor contraindications are frequently reassessed for impact on recipient outcomes in attempt to meet demand for transplantation. This study retrospectively analyzed the United Network for Organ Sharing (UNOS) registry for adult heart transplants from 1987 to September 2016 to characterize the impact of donor malignancy history in heart transplantation. Kaplan-Meier estimates illustrated 10-year survival. Propensity score matching was utilized for 1:1 matching of donors with and without history of malignancy, and Cox proportional hazards and logistic regressions were used to analyze the matched population. Of 38 781 heart transplants, 622 (1.6%) had a donor history of malignancy. Cox regressions demonstrated that donor malignancy predicted increased 10-year mortality (HR = 1.16 [1.01-1.33]), but this difference did not persist when conditioned upon 1 year post-transplant survival (log-rank = 0.643). Cox regressions of the propensity score-matched population (455 pairs) found no association between donor malignancy and 10-year mortality (HR = 1.02 [0.84-1.24]). Older age and higher rates of hypertension were observed in donors with a history of malignancy whose recipients died within the first year post-transplant. Therefore, increased recipient mortality is likely due to donor characteristics beyond malignancy, creating the potential for expanded donor selection.

Impact of Approach and Hospital Volume on Cardiovascular Complications After Pulmonary Lobectomy.

BACKGROUND: Cardiovascular complications contribute significantly to the morbidity and resource utilization after pulmonary resections. Maturation of less-invasive technologies, such as video and robot-assisted thoracoscopic surgery, aims at improving postoperative outcomes by reducing the trauma of surgery. The present work aimed to evaluate changes in cardiovascular complications after open and minimally invasive lobectomies in the United States. METHODS: We performed a retrospective analysis of the Nationwide Inpatient Sample for patients having elective open, video-assisted, and robot-assisted thoracoscopic lobectomy during 2008-2014. Logistic regression was performed to determine predictors of in-hospital mortality, myocardial infarction (MI), cardiac arrest (CA), and postoperative pulmonary embolism (PE). RESULTS: A total of 201,226 patients underwent pulmonary lobectomy over the study period. Open thoracotomy (OPEN) approach has steadily decreased from 75%-52% (P < 0.0001), whereas minimally invasive surgery (MIS) utilization has increased from 25%-48% (P < 0.0001) of all lobectomies. MIS approach was independently associated with decreased odds of mortality (odds ratio [OR] 0.6, 95% confidence interval [CI] 0.50-0.73) and PE (OR 0.67, 95% CI 0.50-0.91). MIS patients at high volume institutions had the lowest odds of all-cause mortality (OR 0.27, 95% CI 0.26-0.53) and MI (OR 0.57, 95% CI 0.38-0.87). Operative approach and institutional lobectomy caseload reduced odds of mortality after MI, CA, or PE. Overall, the incidence of MI, CA, and PE increased. CONCLUSIONS: MIS lobectomies increased without a concurrent reduction in perioperative MI, CA, or PE incidence. High hospital lobectomy volume and MIS approach decrease odds of failure to rescue. Improved perioperative management of cardiovascular risk is warranted to reduce the morbidity, mortality, and resource utilization associated with these complications.

Recipient working status is independently associated with outcomes in heart and lung transplantation.

Employment status may capture elements of patients' physical strength, mental resilience, and socioeconomic status to better prognosticate transplant outcomes. This study characterized the effect of working status on thoracic transplant outcomes by evaluating the United Network for Organ Sharing registry for adult lung or heart transplants from 2005 to 2016. Kaplan-Meier estimates illustrated 5-year and 10-year survival by working status at transplant, while multivariable Cox proportional hazards regressions controlled for baseline differences, including functional and socioeconomic status. Of 17 778 lung transplant recipients, 1700 (9.6%) worked at transplant and experienced significantly lower 5-year mortality than nonworking recipients (38.6% vs 45.5%, P < 0.001). Of 21 394 heart transplant recipients, 1289 (6.0%) were employed and experienced significantly lower 10-year mortality than nonworking recipients (34.1% vs 40.2%, P < 0.001). Adjusted Cox regressions demonstrated that employment significantly reduced mortality independent of functional status for both lung (HR: 0.86 [0.78-0.95], P = 0.003) and heart (HR: 0.84 [0.72-0.97], P = 0.023) recipients. After accounting for insurance status, the effect of working status persisted only in lung transplantation (HR: 0.89 [0.81-0.98], P = 0.023). Since heart and lung transplant candidates employed at transplant face lower long-term mortality, working status must encompass a broad set of physical, psychological, and socioeconomic variables that may prognosticate post-transplant outcomes.

Assessment of Differential Pressures in Chest Drainage Systems: Is What You See What You Get?

BACKGROUND: Dry-suction chest drainage systems are used to achieve proper drainage of the pleural space after cardiothoracic operations. Data on the actual intrapleural pressure during the use of these systems is lacking. The present study was performed to evaluate pressure differences across the circuit using an ex vivo model. METHODS: An ex vivo apparatus coupled to a hospital-grade pleural drainage system was devised to provide calibrated levels of suction and air leak. Simultaneous pressure measurements were obtained at the system outlet and the simulated patient entry site. Trials were conducted with increasing levels of water between the patient and drainage modules at various levels of suction and leak pressures. Signals were recorded at 100 Hz and analyzed using two-way ANOVA. RESULTS: With no obstruction, the drainage system provided precise levels of negative pressure at the patient level (10-40 cm H2O). Addition of fluid in the drainage tubing caused significant differences in transmitted suction (P < 0.001). With increasing air leakage and fluid volume, the pressure differential between the system and patient increased significantly (1.14 to 36.69 cm H2O, P < 0.001). In the off-suction setting, increasing levels of obstruction to 22 cm of water led to development of positive intrapleural pressures (2.6 to 11.1 cm H2O, P < 0.001). CONCLUSIONS: While commercially available chest drainage systems are able to provide predictable levels of suction at the device, intrapleural pressures can be highly variable and depend on complete patency of connecting tubes. Systems capable of modulating the level of suction based on actual intrapleural pressures may enhance recovery after procedures requiring tube thoracotomy.

Lung transplantation in the Lung Allocation Score era: Medium-term analysis from a single center.

In 2005, the Lung Allocation Score (LAS) was implemented as the allocation system for lungs in the US. We sought to compare 5-year lung transplant outcomes before and after the institution of the LAS. Between 2000 and 2011, 501 adult patients were identified, with 132 from January 2000 to April 2005 (Pre-LAS era) and 369 from May 2005 to December 2011 (Post-LAS era). Kruskal-Wallis or chi-squared test was used to determine significance between groups. Survival was censored at 5 years. Overall, the post-LAS era was associated with more restrictive lung disease, higher LAS scores, shorter wait-list times, more preoperative immunosuppression, and more single lung transplantation. In addition, post-LAS patients had higher O2 requirements with greater preoperative pulmonary impairment. Postoperatively, 30-day mortality improved in post-LAS era (1.6% vs 5.3%, P = .048). During the pre- and post-LAS eras, 5-year survival was 52.3% and 55.3%, respectively (P = .414). The adjusted risk of mortality was not different in the post-LAS era (P = .139). Freedom from chronic lung allograft dysfunction was significantly higher in the post-LAS era (P = .002). In this single-center report, implementation of the LAS score has led to allocation to sicker patients without decrement in short- or medium-term outcomes. Freedom from CLAD at 5 years is improving after LAS implementation.

Heparin-Coated Grafts Reduce Mortality in Pediatric Patients Receiving Systemic-to-Pulmonary Shunts.

We aimed to evaluate the outcomes of systemic-to-pulmonary (SP) shunt procedures utilizing heparin-coated (HC) polytetrafluoroethylene (PTFE) vascular grafts compared to uncoated (non-HC) grafts, in order to observe any benefits in pediatric patients. Our institution switched from using non-HC grafts to HC grafts in March 2011. We conducted a retrospective review of consecutive pediatric patients receiving SP shunts from May 2008 to December 2015. Perioperative variables including baseline characteristics, morbidity, mortality, and blood product utilization were evaluated between the HC and non-HC groups. A total of 142 pediatric patients received SP shunts during the study period: 69 patients received HC shunts and 73 patients received non-HC shunts. The HC group had significantly fewer desaturation or arrest events (P < 0.01), fewer shunt occlusions/thromboses (P < 0.01). There was no statistically significant difference in unplanned reoperations between groups (P = 0.18). The HC group demonstrated significantly lower overall 30-day mortality (P < 0.01), as well as shunt-related mortality (P < 0.01). The HC group had significantly lower postoperative packed red blood cell utilization as compared to the non-HC group (P < 0.01). In this study, pediatric patients receiving HC PTFE grafts in SP shunts demonstrated significantly lower shunt-related mortality. The majority of HC grafts remained patent. These findings suggest that HC grafts used in SP shunt procedures may benefit pediatric patients in terms of efficacy and outcomes.

Heart transplantation in children with intellectual disability: An analysis of the UNOS database.

Heart transplantation in children with intellectual disability (ID) is an issue of debate due to the shortage of available donor organs. We sought to perform the first large-scale retrospective cohort study describing the prevalence and outcomes of heart transplantation in this population. The United Network of Organ Sharing database was queried from 2008 to 2015 for pediatric patients (age <19 years) receiving first, isolated heart transplant. Recipients were divided into three subgroups: definite ID, probable ID, and no ID. The chi-square test was used to compare patients' baseline characteristics. Kaplan-Meier and Cox proportional hazard regression analyses were used to estimate the association between ID and death-censored graft failure and patient survival. Over the study period, 565 pediatric patients with definite (131) or probable (434) ID received first heart transplant, accounting for 22.4% of all first pediatric heart transplants (n=2524). Recipients with definite ID did not significantly differ from those without ID in terms of gender, ethnicity, ischemia time, severity of pretransplant condition (waitlist status, mechanical ventilation, inotrope dependence, ECMO, VAD, PVRI, infection prior to transplant), or incidents of acute rejection within the first year. ID was associated with prolonged waitlist time (P<.001). Graft and patient survival at 3 years was equivalent between children with and without ID (P=.811 and .578, respectively). We conclude that intellectual disability is prevalent in children receiving heart transplants, with 22.4% of recipients over the study period having definite or probable ID. ID does not appear to negatively affect transplantation outcomes. Future studies are needed to assess long-term outcomes of transplantation in this population.

Efficacy of an Extracellular Matrix in Systemic Loading Conditions in Congenital Heart Surgery.

Extracellular matrices (ECM) are commonly used to repair congenital heart defects; however, there is a lack of literature pertaining to outcomes with ECM use in high-pressure conditions. Between 2011 and 2014, a total of 202 patients underwent congenital heart disease repair using the ECM placed in a systemic pressure condition. The operative sites included: defects in the ventricular septum, mitral valve, aortic valve, ascending aorta, and aortic arch. Patients were followed and evaluated for mortality and reoperations due to loss of ECM integrity. Echocardiograms were evaluated for graft malfunction such as aneurysmal dilation, VSD formation, valve malfunction, or outflow tract obstruction. Patients were followed for an average of 1492 days (Median = 1583). Out of the 202 patients, 7 (3.5%) died due to complications unrelated to ECM, and 10 (5%) underwent reoperations due to complications of ECM integrity. Reoperations were as follows: two of 6 patients receiving aortic leaflet replacement required reoperation for leaflet failure; four of 12 patients receiving mitral valve leaflet repairs required reoperation for leaflet failure; and four of 142 patients with VSD repair required reoperation for residual shunting. The average time to reoperation was 208 days. There were no outflow tract obstructions or aneurysmal dilatations observed. This modern case series suggests that the ECM is efficacious and sustainable under systemic conditions in congenital heart defect repair. However, concerns remain about the use of ECM in aortic valve repair and infant mitral valve repair. Further studies are needed to evaluate long-term ECM integrity.

Association Between Hematologic and Inflammatory Markers and 31 Thrombotic and Hemorrhagic Events in Berlin Heart Excor Patients.

Bleeding and thrombotic events remain a significant cause of morbidity in pediatric patients supported with ventricular assist devices (VADs). The objective of this study is to identify the association between markers of anticoagulation and bleeding and thrombosis events during Berlin Heart ExCor support. A retrospective, single-center analysis of 9 patients supported with the Berlin Heart ExCor was performed. Inflammatory and anticoagulation parameters including C-reactive protein, fibrinogen, partial thromboplastin time (PTT), and platelet count were measured at 48 and 24 h before and after bleeding or thrombosis events. Patients served as their own controls, and the same parameters were measured during a control period where subjects did not experience either event. All patients received the anticoagulation regimen proposed by Berlin Heart. A total of 31 bleeding or thrombotic events were identified and matched to 18 control events. Patient with predominantly thrombotic events tended to weigh less than those with bleeding events (Δ7.7 kg, p < 0.001). PTT levels were higher before and after bleeding (Δ17.36, p = 0.002) and thrombosis (Δ8.75, p < 0.001) events relative to control. Heparin dose decreased after a thrombosis event (Δ-5.67, p = 0.097), and this decrease was significantly different from control (p = 0.032). Non-collinearity between heparin dose and PTT should prompt further inflammatory and hematological investigation. In addition, heavier patients were more prone to bleeding complications. The role of inflammation in the development of thrombus or hemorrhages in the pediatric VAD population needs to be studied further.